UPLC Method Development and Validation for Sofosbuvir, Velpatasvir, and Voxilaprevir Determination
DOI:
https://doi.org/10.52783/jns.v14.1612Keywords:
Sofosbuvir, Velpatasvir, Voxilaprevir, UPLC, Method Validation, Pharmaceutical Analysis, ICH Guidelines.Abstract
It has been stated that an ideal analytical technique is highly desirable for formulating pharmaceutical prescription. This work describes and validates the new UPLC method for the identification of Sofosbuvir, Velpatasvir, and Voxilaprevir in drug products. Details of developed method was checked for precision, accuracy, linearity, sensitivity and robustness and found it abide ICH guidelines for validation. The chromatographic separation was done on a C18 column and a gradient mobile phase of acetonitrile and buffer at certain conditions. All the analytes were estimated at 260 nm. The selected method displayed a perfect linear response within high concentration levels of the drug more than 0.999 with the merits values for all three drugs. Validation results provided further support to the suitability of the described method in routine quality control analysis where this approach would stabilize pharmaceutical quality assurance in terms of rapidity and cost-effectiveness.
Downloads
Metrics
References
Harmeet kaur Bhatia, Harmanjit singh, Grewal N, Natt N. Sofosbuvir: A novel treatment option for chronic hepatitis C infection. J Pharmacol Pharmacother. 2014; vol 5, p 278-284.
L. Memthoibi Devi, Dr T. Ram Mohan Reddy and Dr K.Abbulu. Simultaneous determination and validation of third generation antiviral drugs by RP-HPLC method. Int. J. of Pharmacy and Analytical Research.2019; vol 8(1), p 01-08.
J. Sandya Rani and N.Devanna. Development and validation of RP-HPLC method for the simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in bulk and tablet dosage forms. Rasayan J. Chem. 2018; vol 11(2), p 452 – 459.
Marakada Sridevi, Dr.T.Siva Rao and Challa Gangu Naidu. Development and validation of liquid chromatographic method for simultaneous estimation of sofosbuvir, velpatasvir and voxilaprevir in fixed tablet dosage form. European Journal of Biomedical and Pharmaceutical Sciences 2018; vol 5(5), p 351-360.
B. Balaswami, P. Venkata Ramana, B. Subba Rao and P. Sanjeeva. A new simple stability-indicating RP-HPLC- PDA method for simultaneous estimation of triplicate mixture of sofosbuvir, velpatasvir and voxilaprevir in tablet dosage form. Research J. Pharm. and Tech. 2018; vol 11(9), p 4147-4156.
Kalpana nekkala1 et al. Analytical method development and validation for the simultaneous estimation of sofosbuvir and velpatasvir drug product by reverse phase high performance liquid chromatography method, Asian J Pharm Clin Res 2018; vol 11(2), p 164-168.
Kokkirala, T., & Suryakala, D. (2020). Stability indicating RP-HPLC Method development and Validation for the Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Pharmaceutical dosage form. Research Journal of Pharmacy and Technology, 13(11), 5063-5071.
Nalla, S., & Rao, J. V. L. N. S. (2017). A stability indicating RP-HPLC method for simultaneous estimation of velpatasvir and sofosbuvir in combined tablet dosage forms. World Journal of Pharmacy and Pharmaceutical Sciences, 6(9).
Nagaraju, T., Vardhan, S. V. M., Ravi Kumar, D., & Ramachandran, D. (2017). A new RP-HPLC method for the simultaneous assay of sofosbuvir and ledipasvir in combined dosage form. International Journal of ChemTech Research, 10(7), 761-768.
Sattar, M. A., & Suneetha, A. (2018). RP-HPLC Method development and validation for velpatasvir and voxilaprevir by simultaneous determination in bulk and their pharmaceutical dosage forms. International Journal of Chemical and Pharmaceutical Sciences, 6(1), 36–42.
Sridevi, M., Siva Rao, T., & Gangu Naidu, C. (2018). Development and validation of liquid chromatographic method for simultaneous determination of sofosbuvir, velpatasvir and voxilaprevir in fixed tablet dosage form. European Journal of Biomedical and Pharmaceutical Sciences, 5(5), 351-360.
Dongala, T., & Palakurthi, A. K. (2019). Stability‐indicating LC method for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha‐tocopherol contents in marijuana capsules. Journal of the Iranian Chemical Society.
Subramanian, V. B., Katari, N. K., Dongala, T., & Jonnalagadda, S. B. (2020). Stability‐indicating RP‐HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach. Biomedical Chromatography, 34(1), e4719.
Kumar, P. A., Raju, T. V. R., & Thirupathi, D. (2013). Development and Validation of a Stability-Indicating LC-Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities. Scientia Pharmaceutica, 81, 139-150.
Dongala, T., Katari, N. K., Palakurthi, A. K., & Jonnalagadda, S. B. (2019). Development and validation of a generic RP‐HPLC PDA method for the simultaneous separation and quantification of active ingredients in cold and cough medicines. Biomedical Chromatography.
Dongala, T., Katari, N. K., Palakurthi, A. K., & Jonnalagadda, S. B. (2019). Stability-indicating HPLC method for simultaneous quantification of 14 impurities in Excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies. Biomedical Chromatography.
Kancherla, P., Alegete, P., Keesari, S., & Khagga, B. (2016). Stability-Indicating RP-UPLC Method Development and Validation for the Process Related Impurities of Nebivolol and Structural Characterization of Its Forced Degradation Products by LC-MS/MS. British Journal of Pharmaceutical Research, 14(6), 1-13.
Katakam, L. N. R., & Dongala, T. (2020). Quality by design with design of experiments approach for the development of a stability‐indicating LC method for benzonatate and its impurities in liquid oral dosage form. Separation Science Plus.
Palakurthi, A. K., Dongala, T., Yalavarthi, R. K., & Anireddy, J. (2020). QbD based development of extraction procedure for simultaneous quantification of telmisartan, amlodipine besylate and chlorthalidone in combination complex matrix formulation. Biomedical Chromatography, e4755.
Kumar, P. A., Thirupathi, D., Kumar, Y. R., & Jayashree, A. (2017). Simultaneous Determination of Related Organic Impurities of Ibuprofen and Paracetamol in Combination Solid Dosage Form by RP-HPLC with QbD Approach. Oriental Journal of Chemistry, 33(3).
Castiñeira-Landeira, A., Sasse, S., Broeren, M., Sterk, S. S., & Arrizabalaga-Larrañaga, A. (2024). Method Development and Validation for the Simultaneous Determination of 21 Antiviral Drugs by Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry in Chicken Muscle and Liver. SSRN Electronic Journal.
Susmita, A. G., & Rajitha, G. (2018). Development and Validation of Stability Indicating UPLC Method for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Tablet Dosage Form. International Journal of Pharmaceutical Sciences and Research, 9(11), 4764-
Kazi, M., Al-Amri, K. A., & Alanazi, F. K. (2019). Development and validation of a UPLC method for quantification of antiviral agent, Acyclovir in lipid-based formulations. Arabian Journal of Chemistry, 12(8), 1707-1714.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
